1. Field of the Invention
The invention relates to packaging for products such as disposable medical devices, and more particularly, concerns packaging for a plurality of identical disposable medical devices, such as syringes, catheters or the like.
2. Background of the Invention
Disposable medical devices are sold in groups of like size and type which are typically carried in an over carton in a dozen or more individually packaged, identical devices. A package can be removed from the over carton and opened to obtain a single disposable device. Individual packaging maintains a sterile barrier for each disposable medical device. Consequently, the package for each should be inexpensive, easy to open without contamination of the product and structurally adequate to protect the product prior to use.
Commonly used packaging for disposable medical devices include two components; a flat top or cover with printed product information as, for example, product size, type, name of manufacturer, instructions and the like. The top or cover is usually a thin sheet of extrusion coated paper having a polyethylene layer and a heat sealable lacquer layer. The paper is called Thillmany paper and the polyethylene is added for tear resistance.
The other or second component of the often used package is a drawn semi rigid tub which has a recess for receiving the product and a flange for supporting the top or cover. The tub is thermoformed from semi rigid polystyrene sheet which is heated and drawn such that the depth of the recess is no more than one and one-half times the width. Products which are wider than they are deep have to be packed sideways or the package has to be drawn less than required for efficient use of the drawn polystyrene material. Typically, the flange is the thickest part of the formed tub in that it is not drawn and the corners of the recess are the thinnest area because they are stretched the most. A ratio of flange thickness to corner thickness of six to one is about the maximum amount of thinning that can be accomplished with an economical starting thickness for the polystyrene sheet. The flange protects the device and provides support during opening.
The cover and tub flange are heat sealed to securely enclose the product within the recess of the tub but a portion along an edge is usually left unsealed in order to provide an area where the top can be peeled from the flange. In particular, the unsealed portion of edge of the top can be fanned away from the edge of the flange and then grasped and peeled away from the heat sealed areas about the rest of the flange. The product remaining within the recess is supported thereby during peeling. After removal of the top or cover, the product can be accessed without having violated the sterile field of the product but the use of gloved hands is necessary to maintain sterility. Since the product and package are typically sterilized after assembly but before use, the package has to remain a barrier to microbes and the like until the described opening procedure is performed.
There are disadvantages with the presently used packages including the amount of material, the time in processing the ease of use. The material problem is the original thickness of the styrene semi-rigid film needed to form an adequate recess for the product. A rather generic shape of recess is usually required to provide the space necessary to accommodate the product. Printing on the tub prior to forming will be distorted during forming unless complicated pre-distorted printing is used or difficult after forming printing is applied.
While less material and cheaper packaging films are available, such as, the use of a single wrap of material forming a tube with heat sealed ends, that approach will not adequately protect the product after assembly and will not support the product during opening. Consequently, the two component, tub and top package is commonly used for packing disposable medical devices.
An inexpensive preprinted package of a thin material is desired. The package has to open in a manner which will protect the sterile product and allow the parts of the package to be separated without loss of the sterile field or of the support of the product. The package should also protect the product after assembly and prior to package opening for use. That is to say that sufficient package rigidity is needed to prevent damage to the product during shipping and unwrapping. Disposable medical devices are usually made of molded polymeric materials and carry a hollow metal needle at one end. Medical products have light and accurately made parts designed to be handled gently when administering medication. Those medical products are such that the packaging is particularly important in preventing damage prior to use.
High volume production techniques and equipment used to manufacture disposable medical devices permit low unit cost and single use. Single use is important in preventing the spread of disease and infection. Consequently, any improvement which will lower the manufacture, assembly or shipping expense is of value in connection with maintaining the lowest possible unit cost and assuring a practical single use product. The package for a disposable medical device should have a minimum cost as the package has a shorter life than the device. In addition, minimizing the package lessens the amount of material which must be disposed of upon removal of the product. Disposable medical devices are packed in an over carton or shipper for carrying a group of similarly sized products. The individual packaging of each device should facilitate the placement of a group into the over carton and allow easy removal of a single packed device.
U.S. Pat. No. 4,444,310 discloses a segmented multi-product package containing articles such as hypodermic syringe tip caps. There is a tray which contains a plurality of receptacles having open ends associated with an upper surface of the tray. A sealing area around the upper surface lies between adjacent open ends and the cover is removably sealed across these areas to cover the receptacles and enclose the syringe tip caps. This is a typical package for disposable medical products as described.
U.S. Pat. No. 4,438,845 discloses a package for a syringe having top and bottom chambers with a platform therebetween and an elongate opening in the platform provides an entrance opening into the bottom chamber such that syringes when discarded are deposited in the bottom chamber. This package represents essentially two of the common flat top packages herein before described placed against one another.
U.S. Pat. No. 4,015,709 includes a container in the form of an elongate tray for carrying a plurality of syringes with a removable label or cover heat sealed over the open top of the tray. The bottom wall of the tray includes notches for holding and positioning the syringes. This reference has a plurality of syringes carried in a common package using the conventional tray with a flat cover. U.S. Pat. No. 3,305,084 has a package similar to that shown in the '709 patent but the container top is formed and not flat. Again, the syringes are carried as a plurality of products separated in a tray with a notched bottom surface. Individual syringes can not be accessed without disturbing the sterility of others.
U.S. Pat. No. 4,699,291 teaches a package with first and second housing portions, each with a generic shaped recess and a flanged periphery. When the flanges are positioned adjacent to and engaged with one another, an article compartment is defined. The flanges are secured with a removable tube, slit longitudinally and positioned for causing positive engagement of the flanges to one another to maintain the housings together. Dimples may be included along the flanges in order to retain the tubing in position.
U.S. Pat. No. 3,454,210 has a package with a top and base member each having a preformed pocket, preselected areas about the pocket are bonded together to hold the package closed. The pockets are of a rather generic shape and there is no specific disclosure of the present semi rigid and formed package for individually securing disposable medical devices.